Senate approves PDUFA

Senate votes to reauthorize PDUFA

AstraZeneca applauds the United States Senate for voting today to reauthorize the Prescription Drug User Fee Act, a law that authorizes the US Food and Drug Administration to collect fees from biopharmaceutical companies to help pay for the regulatory review process of medicines and biological products.

As we’ve recently written about here, PDUFA provides much needed resources to the FDA. We hope that the resulting legislation will lead to a more efficient, predictable, transparent and well coordinated drug review process within the FDA while strengthening the scientific base at the agency, supporting patient safety and promoting innovation.